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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

FDA Reissues Rule to Protect Whistleblowers from Retribution

In January 2013, the US Food and Drug Administration (FDA) published something of an unusual notice in the Federal Register. The notice indicated that FDA would withdraw a final rule that had been published just a few months prior, thereby permitting access to records regarding scientific research misconduct proceedings involving its staff. Now the agency has announced the reinstatement of the final rule, saying the records are now exempt from certain requirements under the federal Privacy Act of 1974.

Background

The Privacy Act established rules regarding the use and release of information about people contained in federal databases. In general, US agencies and departments are required to release information they have generated as part of their routine duties upon request.

The problem as it currently stands, argued FDA, is that under the&nbsp;Privacy Act, employees have the right to access information pertaining to them within any non-exempt system of records. Because their current misconduct system is not explicitly exempt, any person under investigation could legally request those records, including information regarding the investigation and the identity of the person or persons who accused them of misconduct.

This could lead to a chilling effect on report of plagiarism, as the reporting person or persons could be singled out for retribution.

In its regulation, FDA said it would exempt its "system of records" on research misconduct proceedings involving FDA staff in order to "protect the integrity of FDA's scientific misconduct inquiries and investigations and to protect the identity of confidential sources in such investigations."

Investigations can ultimately result in debarment and suspension from being allowed to conduct government-sponsored research, as well as civil or criminal penalties depending on the scope of the misconduct.

A New System

The agency explained in its 28 August 2012&nbsp;Federal Register&nbsp;notice that its proposed system of records would be modeled after the Office of Research Integrity's (ORI), the Department of Health and Human Services (DHHS) office charged with overseeing allegations of misconduct involving basic, government-funded research.

In particular, FDA is claiming that under section 552a(k)(2) of the Privacy Act, it may exempt records "containing investigatory material compiled for law enforcement purposes." While federal law would still permit an employee to access records of claims made against them, the records would no longer reveal the identity of the source who provided that information to FDA or the government in the first place.

Removal

The regulation had originally been put forth as a "direct final rule," which is unusual in that it calls for comments even though it did not go through the advanced notice of public rulemaking (ANPR) process. FDA's 1997&nbsp;guidance on the use of direct final rule procedures&nbsp;notes that it only uses it "when the agency does not anticipate receiving any significant adverse comment, or when a rule may qualify for exemption from notice-and-comment rulemaking."

FDA said it did not anticipate any "significant adverse comments" on the rule, but noted that if it did it would withdraw the rule and reissue it under normal circumstances.

However, FDA said it ultimately received three comments on the rule, with one "broadly" opposing the exemptions "as a governmental over-reach restricting citizen's ability to maintain awareness of the actions of regulatory bodies." FDA determined that this was a significant and adverse comment, and withdrew the rule in January.

The text of those comments has not been made available on the Regulations.gov website, where FDA's comments docket is maintained.

Reissue

As Regulatory Focus explained at the time, the rule was expected to re-enter the rulemaking process as an ANPR, allowing for a public comment and revision process.

As expected, FDA explained in its Federal Register notice that "HHS/FDA now publishes this final rule under the standard notice and comment rulemaking process," adding that it believes the exemptions remain "necessary to fulfill the Agency's responsibility for addressing research misconduct."

"Failure to adopt the exemptions would jeopardize the integrity and effectiveness of FDA's research misconduct proceedings," FDA added. However, FDA said it would give "case-by-case consideration to requests for notification, access and amendment."

"Except for information that would reveal the identity of a source who was expressly promised confidentiality, the access exemption will not prohibit HHS/FDA from granting respondents' access requests," it added.